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Submitting a 510(k)? Keep Hoarding Blank CDs

FDA Law Blog

Lenz, Senior Medical Device Regulation Expert — FDA introduced electronic copies (eCopies) of 510(k)s in 2013 (see our prior blogs here and here ) as a way to reduce the need for submission of paper copies of 510(k)s to the Agency. This pilot program, which utilized FDA’s eSubmitter electronic submission template, ended in May 2021.

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Episode 213: Antiracism in Medicine Series – Episode 13 – Centering Asian Americans: Racism, Violence, and Health

The Clinical Problem Solvers

difficulty of sending patient messages through the electronic medical record in languages other than English), limited healthcare literacy, and English-only signage on healthcare campuses are just a few of the structurally racist barriers faced by many Asian folks seeking healthcare. Insufficient language services (i.e., Harvard Law School.